Summary
If you have experience managing clinical trials and providing regulatory support AND you want to play a significant role in a dynamic organization, then consider joining the Center for Cancer Research (CCR), Office of the Clinical Director (OCD) at the National Cancer Institute (NCI)! For more information please visit: https://ccr.cancer.gov/about/office-of-the-clinical-director.
This job is open to
Clarification from the agency
You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.
Duties
As a Regulatory Affairs Specialist, your typical work assignments may include:
- Managing all aspects of the protocol lifecycle including scientific peer review, initial Investigational New Drug Applications (IND) preparation, Institutional Review Board (IRB) submission of protocols, continuing review applications, protocol amendments, and annual reports.
- Monitoring key ethical and legal issues related to protection of research participants, adherence to policies and federal and state regulations surrounding the collection, storage, dissemination, and use of biospecimens.
- Serving as a liaison for clinical Investigators and other clinical regulatory staff
- Providing regulatory guidance, review, and expertise to ensure documentation conforms to applicable regulations and guidelines.
- Coordinating study site activities pertaining to the compilation and submission of, Institutional Review Board (IRB) applications, including documents for original Investigational New Drug Applications (INDs) for management and multi-disciplinary team review.
- Preparing and compiling data from ongoing protocols and drafts annual continuing review reports for distribution to appropriate regulatory agencies.
Requirements
Conditions of Employment
- U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
- Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
- Applicants must meet all qualification requirements by the closing date of this announcement.
- Males born after December 31, 1959 must be registered with the Selective Service.
- Position has an education requirement. Please submit transcripts.
Qualifications
Basic Qualifications
In order to qualify for a Regulatory Affairs Specialist, GS-0601, position you must have successfully completed a Bachelor's degree or graduate/higher level degree with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. (This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education (https://ope.ed.gov/accreditation) at the time the degree was obtained).
Additional Qualifications
GS-12:
In addition, to qualify for a Regulatory Affairs Specialist position at the GS-12 level, you must demonstrate at least one year of specialized experience equivalent to at least the GS-11 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks: monitoring clinical trials to ensure applicable regulations, guidelines, and clinical practices are followed; serving as liaison and providing regulatory guidance for clinical investigators and other clinical regulatory staff; reviewing and submitting Investigational New Drug Applications (IND) and Investigational Device Exemptions (IDE) to review committees and regulatory bodies; and providing administrative and technical support to investigators involved in clinical trial research efforts.
GS-13:
In addition, to qualify for a Regulatory Affairs Specialist position at the GS-13 level, you must demonstrate at least one year of specialized experience equivalent to at least the GS-12 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks: managing a portfolio of clinical trials to include protocol navigation, regulatory support and document preparation; serving as liaison and providing regulatory guidance for clinical investigators and other clinical regulatory staff; coordinating submission of protocols to scientific review panels/committees for consideration; preparing and submitting Investigational New Drug Applications (IND) and Investigational Device Exemptions (IDE) to review committees and regulatory agencies; and providing administrative and technical support to investigators involved in clinical trial research efforts.
You will receive credit for all experience material to the position, including experience gained in religious, civic, welfare, service, and organizational activities, regardless of whether you received pay.
Do not copy and paste the duties, specialized experience, or occupational assessment questionnaire from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position.
Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12412946
Education
This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades). Unofficial transcripts will be accepted in the application package. Official transcripts will be required from all selectees prior to receiving an official offer. Click here for information on Foreign Education.
Benefits
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Review our benefits
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
How You Will Be Evaluated
You will be evaluated for this job based on how well you meet the qualifications above.
You will be assessed on the following competencies (knowledge, skills, abilities, and other characteristics):
- 1. Ability to manage clinical trial portfolios.
- 2. Knowledge of cancer therapy and cancer diagnostic test regulations and reporting requirements.
- 3. Skill in developing and submitting Institutional Review Board/Ethics Board applications, Investigational New Drug and Investigational Device Exemptions applications and requests.
- 4. Skill to effectively communicate technical and program related information.
If you meet the minimum qualifications for this position, your application and responses to the online questionnaire will be evaluated under Category Rating and selection procedures for placement in one of the following categories:
- Best Qualified - for those who are superior in the evaluation criteria
- Well Qualified - for those who excel in the evaluation criteria
- Qualified - for those who only meet the minimum qualification requirements
The Category Rating Process does not add veterans' preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Applicants determined to be Best Qualified will be referred for further consideration. Preference eligibles in the Best Qualified category are referred before all other applicants.
To determine your qualifications and referral status, we may review your resume and supporting documentation and compare it against your responses to the vacancy questionnaire. Ensure you support your self-ratings by the information you provide in your application. We may verify or assess your qualifications at any time. Inflated or unsupported qualifications may affect your rating. Any misrepresentation or material omission of facts may be sufficient cause to end further consideration of your candidacy. Persons listed as having knowledge of your past accomplishments or experience in your application may be contacted for verification purposes at any time. Verification may, but need not, begin prior to receiving an offer.
To be considered well qualified for the purposes of the Career Transition Assistance Program (CTAP) and the Interagency Career Transition Assistance Program (ICTAP), you must be able to satisfactorily perform the duties of the position upon entry and substantively exceed the basic qualifications by scoring at least an 85 on the assessment and meet all eligibility, physical, medical, suitability, and all other requirements.
Required Documents
REQUIRED FOR ALL APPLICANTS
RESUME:
Your resume must thoroughly describe how your skills and experiences align to the criteria defined in the "Qualifications" section of this announcement and it must support your responses to the assessment questionnaire. We cannot assume you have performed the necessary experience required for this position regardless of your employment history or academic career.
To ensure all of the essential information is in your resume, we encourage you to use the USAJOBS online Resume Builder. If you choose to use your own resume, you must ensure it contains all of the required information and you organize it so we can associate the following information for each experience/position:
- Job title
- Name of employer
- Beginning and ending dates of employment (month/day/year format)
- Hours worked per week. We will assume full-time unless otherwise stated. We will prorate part-time employment in crediting experience.
- Detailed description of job duties, accomplishments, related skills, and responsibilities to include any supervisory/managerial responsibilities and number of staff supervised (if applicable)
- Series and grade or equivalent (if a federal position)
If the position has an education requirement or you are qualifying on the basis of education, you must list your education history including the type of degree and your major of study. If the position requires a certain number of credit hours, you are strongly encouraged to list the relevant courses in your resume.
Do not include a photograph or video of yourself, or any sensitive information (age, date of birth, marital status, protected health information, religious affiliation, social security number, etc.) on your resume or cover letter. We will not access web pages linked on your resume or cover letter to determine your qualifications.
For resume writing guidance, please visit the following resources: NIH Jobs website, USAJOBS Resource Center, and the USAJOBS Resume Writing Video Tutorial.
ASSESSMENT QUESTIONNAIRE:
You must submit a completed assessment questionnaire.
Unless otherwise stated, we will only use the information above to determine your qualifications. Not providing the required information may result in a determination that you do not meet minimum requirements for the position (e.g., an ineligible rating) or a lower rating.
REQUIRED DOCUMENTATION FOR PREFERENCE OR ELIGIBILITY CLAIMS
To claim veterans' preference, career transition selection priority, Schedule A or military spouse eligibility, you must provide the documentation listed below AND respond accordingly to the associated question on the online questionnaire.
- Veterans' preference (DD-214, VA Disability Letter, etc.): Reference Standard Form 15 (SF-15) for required documentation for 10 point claims. Submission of SF-15 is not required, unless you are claiming derived preference (XP) as described in questions 7, 8, or 9 on the SF-15. In those cases, you must submit a completed SF-15 and the required documentation. For 5 point claims, you must submit your DD-214 (if separated) or any written documentation from the armed forces that certifies you are expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package.
- Visit our sites on Career Transition Assistance Program (CTAP)/Interagency Career Transition Assistance Program (ICTAP) for more information and required documentation.
- Visit our site on the Appointment of Certain Military Spouses for more information and required documentation to verify eligibility.
- Schedule A Eligibility (Applicants with Disabilities) Applicants who are eligible to be considered under Schedule A must submit appropriate documentation to verify eligibility. Documentation must be obtained from a licensed medical professional (e.g., a physician or other medical professional certified by a state, the District of Columbia, or a U.S. territory to practice medicine); a licensed vocational rehabilitation specialist (i.e., state or private); or any Federal agency, state agency, or agency of the District of Columbia or a U.S. territory that issues or provides disability benefits. The letter must be printed on a medical professional's letterhead and signed. Veterans' preference takes precedence in these appointments.
The Schedule A and military spouse hiring authorities do not guarantee employment or give an individual preference in the hiring process.
If you do not provide the required information, we will assume you are not eligible, or you do not wish to be considered for any preference or eligibility.
Do not submit documentation that is not requested of you. To protect your personal information, we will only send your resume and cover letter to the selecting official or hiring manager.
If you are relying on your education to meet qualification requirements:
Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from
schools accredited by accrediting institutions recognized by the U.S. Department of Education.
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.
How to Apply
To apply for this position, please read and follow all instructions in this announcement, complete the online application, and submit the documentation specified in the "Required Documents" section. Your complete application package must be submitted by 11:59 PM Eastern Time (ET) on 07/01/2024 to receive consideration.
- To begin, click Apply to access the online application. You will need to be logged into your USAJOBS account to apply.
- Follow the prompts to select your resume and/or other supporting documents to be included with your application package. See the "Required Documents" section for any additional forms and/or supplemental materials required.
- Read all Eligibility questions and respond accordingly to any Eligibility you wish to claim. You will only be considered for those Eligibility questions (Status Applicant, Reinstatement, Schedule A, etc.) you respond in the affirmative to, regardless of what documentation you submit. We cannot assume you intended to respond differently to a question based on other information in your application package.
- Complete the assessment questionnaire. Applicants are asked all questions regardless of their consideration preferences. We will only consider you for the grades, series, locations, specialties, and other considerations that you self-identify as being qualified for or interested in. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12412946
- Verify all required documentation is included in your application package, review your responses to the assessment questionnaire for accuracy, and then submit your application.
In addition to the required documents, we encourage you to submit a cover letter, copy of your transcripts, and any applicable certifications or licenses. Even though this information is not required at the time of application, we may request this information later.
We cannot assume responsibility or grant extensions for personal issues (e.g., troubles navigating the application process, loss of internet, not understanding a question) when applying to our announcements. For technical difficulties, contact HR Systems Support between 8:00 AM and 4:30 PM ET Monday through Friday at hrss@nih.gov.
If you need any other accommodation or assistance with applying, please contact Jamie Hammond at hammondje@mail.nih.gov. Requests for reasonable accommodations must be made before the announcement closing date.
NIH's EEO and Diversity and Inclusion Policy Statement
Visit the NIH's Office of Equity, Diversity, and Inclusion site for information on NIH's EEO program, Reasonable accommodation procedures, laws, policy statements, and the operation of the EEO complaint process.
Next steps
HHS has a critical preparedness and response mission: HHS protects the American people from health threats, researches emerging diseases, and mobilizes public health programs with domestic and international partners. In support of this mission, HHS offers its employees the opportunity to volunteer to become Federal Civilian Detailees and contribute their unique skills through voluntary temporary assignments to humanitarian emergencies or Departmental priorities countering new and emerging health, safety, and security threats.
Once you submit your application package, you will receive an acknowledgement email. You will be notified of the status of your applications via email. In addition, you can track the progress of your application package through your USAJOBS account.
At the discretion of the agency, you may be contacted via phone or email for an interview or to provide additional information up to several months from the closing date of the announcement. Please ensure you have provided accurate contact information. To remain in consideration, you must respond in a timely manner to our correspondence and requests for documentation or information throughout the hiring process.
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